Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

This research study is looking into a new medication called vimseltinib for people with advanced cancers and a particular joint condition known as Tenosynovial Giant Cell Tumor (TGCT). TGCT is a rare condition where a tumor grows in the joints, often causing pain and swelling. The study has two main parts: first, finding the safest and most effective dose of vimseltinib, and then, in the second part, further testing the drug especially in people with TGCT. This is to see how well the treatment helps manage their condition and symptoms. It's an important step in developing new treatment options.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Deciphera Pharmaceuticals, LLC

Enrolment target

120

Start

16 Feb 2017

Estimated completion

01 Aug 2028

Advanced Malignant Neoplasm Pigmented Villonodular Synovitis Giant Cell Tumor of Tendon Sheath Tenosynovial Giant Cell Tumor Tenosynovial Giant Cell Tumor, Diffuse

What is this study about?

This study is a clinical trial exploring a new drug named vimseltinib. It's designed for people who have either advanced solid cancers or a specific joint condition called Tenosynovial Giant Cell Tumor (TGCT). TGCT is a rare type of tumor that grows in the soft tissues of joints, like the knee or hip, and can cause pain, swelling, and limited movement. Sometimes surgery isn't possible or hasn't worked well.

The study has two main stages. The first stage, called 'Phase 1', is about finding the best and safest dose of vimseltinib. During this stage, both people with advanced cancers and those with TGCT will be included. Once the right dose is found, the study moves into 'Phase 2'. This second stage will focus specifically on people with TGCT, to gather more information on how effective vimseltinib is at treating their condition.

The main goal of this research is to see if vimseltinib can be a helpful new treatment option for these conditions, especially for TGCT when other treatments haven't been suitable. Taking part in a study like this helps doctors learn more about new medicines and how they might improve care in the future.

Key takeaways

Tests a new drug, vimseltinib, for certain advanced cancers and TGCT.
Aims to find the safest dose and see how well it works.
Open to adults aged 18 and over.
Especially focused on TGCT when surgery isn't possible.
Requires regular clinic visits and monitoring.
Participation is voluntary, and you can leave at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. If you have advanced solid cancer, you will generally need to provide a tissue sample from your tumor and show that your cancer can be measured. You also need to be well enough to carry out most daily activities.

If you have Tenosynovial Giant Cell Tumor (TGCT), your symptoms must be ongoing and surgery must not be a suitable option for you. If you haven't had a biopsy to confirm your TGCT diagnosis yet, you might need one to join. For some parts of the study, if you have TGCT, you might also need to have tried other similar treatments before.

All participants will need to have healthy enough organs and blood counts. If you are a woman who could become pregnant, you'll need to have a negative pregnancy test before starting and agree to use birth control during the study. You will also need to sign a consent form, showing you understand and agree to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced solid cancer or Tenosynovial Giant Cell Tumor (TGCT) where surgery isn't an option?
Are your organs and blood counts generally healthy?
If you are a woman, are you able to use birth control during the study if needed?
Are you willing and able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given the study drug, vimseltinib. The study will involve regular visits to the clinic for check-ups, where health professionals will monitor your progress and any side effects. You'll have blood tests, physical examinations, and possibly scans to see how the treatment is working. The exact number of visits and tests will depend on which part of the study you are in.

For those with advanced cancers, your participation will help doctors determine the safest dose. For those with TGCT, the study will also look at how effective the drug is over time. You will be closely monitored throughout your time in the study, and the medical team will be on hand to answer any questions and address concerns. The total length of time you will be in the study will depend on how you respond to the treatment and the study's design.

Potential risks and benefits

Taking part in this study could potentially offer you access to a new treatment, vimseltinib, that might help manage your condition, especially if other treatments haven't worked or aren't suitable. However, as with any new drug, there are potential risks, and you may experience side effects. These will be fully explained to you before you decide to join. There’s also no guarantee that the treatment will be effective for you. You are free to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (24)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Stanford Cancer Institute
Verified postcode
Palo Alto, United States
University of Colorado - Denver
Verified postcode
Denver, United States
Mayo Clinic
Verified postcode
Jacksonville, United States
University of Miami
Verified postcode
Miami, United States
Dana Farber
Verified postcode
Boston, United States
MSKCC
Verified postcode
New York, United States
OHSU
Verified postcode
Portland, United States
Oregon Health & Science University
Verified postcode
Portland, United States
Sarah Cannon Research Institute
Verified postcode
Nashville, United States
Peter MacCallum Cancer Centre
Verified postcode
Melbourne, Australia
McGill University Health Centre
Verified postcode
Montreal, Canada
Princess Margaret Cancer Center
Verified postcode
Toronto, Canada

Common questions

What is Tenosynovial Giant Cell Tumor (TGCT)?

TGCT is a rare, non-cancerous tumor that grows in the lining of joints, causing swelling and pain. Sometimes it can be cancerous (malignant).

What is vimseltinib?

Vimseltinib is a new medication being tested in this study to see if it can treat advanced cancers and TGCT.

Will I know if I'm getting the drug or a placebo?

This study is 'open-label,' meaning everyone who participates will receive the drug, vimseltinib. There is no placebo group.

What does 'advanced solid tumors' mean?

'Advanced solid tumors' means cancers that have spread or are at a later stage, not including blood cancers.

How long will I be in the study?

The length of your participation will depend on how the treatment works for you and other study details. This will be discussed with you before you start.